NCT00936403|CompletedPhase 2

A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN8630-18242008-008240-25

Study Type

interventional

Target

Locations

10 countries

Sites

Timeline

RegisteredJul 2009

StartedAug 2009

CompletionJul 2010

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach

10 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

July 9, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed

22 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

July 9, 2009

Last Update Submit

February 6, 2017

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (1)

Frequency of Adverse events (AEs)
0-10 days after dosing

Secondary Outcomes (2)

AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration
Measured 10 days after dosing
IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration
Measured 10 days after dosing

Study Arms (2)

NNC126-0083

EXPERIMENTAL

Drug: NNC126-0083

Norditropin NordiFlex®

ACTIVE COMPARATOR

Drug: somatropin

Interventions

NNC126-0083DRUG

One single dose administered in four dose levels in an escalating order

NNC126-0083

somatropinDRUG

A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant

Norditropin NordiFlex®

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
Pre-pubertal children
Growth hormone replacement treatment for at least three months

You may not qualify if:

Evidence of tumour growth or malignant disease
Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)

Contact the study team to confirm eligibility.